• Bachelor's degree or higher in software engineering, computer science, electrical/electronic engineering or a closely related field.
• Minimum 4 years of professional experience in the medical device industry or another safety-critical sector, including a minimum of 2 years designing, developing or testing safety-critical software.
• Prior work as a Product Reviewer (technical documentation assessor) for a notified body or UK approved body, covering software devices (e.g. MDA 0315 / MDS 1011).
• Working knowledge of IEC 62304, IEC 82304-1, ISO 14971, IEC 62366-1 and medical device cybersecurity (e.g. IEC 81001-5-1, MDCG 2019-16).
• Practical experience with software development fundamentals: lifecycle processes, verification and validation testing, configuration management and cybersecurity.
• Evidence of confidently interpreting and applying regulatory requirements to software technical documentation.
• Evidence of delivering consistent, high-quality technical documentation assessments.
• Experience assessing software as a medical device (SaMD).
• Ability to explain findings and requirements clearly and constructively, in writing and verbally.
• Ability to deliver assessments independently with minimal oversight.
• Willingness to adopt Scarlet's values, assessment methods and tooling.
• Experience assessing AI/ML-enabled medical devices.
• Practical experience with generative AI, such as LLMs, embeddings, RAG, fine-tuning and evaluation/monitoring.
• Familiarity with relevant guidance such as MDCG 2019-11 (software qualification and classification) and MDCG 2020-1 (clinical evaluation of software).